Evolocumab Side Effects

For the Consumer

Applies to evolocumab: subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by evolocumab. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking evolocumab:

• Difficulty with breathing or swallowing
• fever
• hives, itching, or rash
• nausea
• reddening of the skin, especially around the ears
• swelling of the eyes, face, or inside of the nose
• unusual tiredness or weakness

Minor Side Effects

Some of the side effects that can occur with evolocumab may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

• Back pain
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• body aches or pain
• chills
• cough
• ear congestion
• headache
• loss of voice
• muscle aches
• sneezing
• sore throat
• stuffy or runny nose

• Abdominal or stomach pain
• bladder pain
• bloody or cloudy urine
• blurred vision
• diarrhea
• difficult, burning, or painful urination
• difficulty with moving
• dizziness
• frequent urge to urinate
• loss of appetite
• lower back or side pain
• muscle aching or cramping
• muscle or joint pain
• muscle stiffness
• nervousness
• pain or tenderness around the eyes and cheekbones
• pounding in the ears
• slow or fast heartbeat
• swollen joints

For Healthcare Professionals

Applies to evolocumab: subcutaneous solution

Cardiovascular

Common (1% to 10%): Hypertension^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, gastroenteritis, nausea (1.8%)^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reactions (including rash, eczema, erythema, urticaria)^[Ref]

Local

Common (1% to 10%): Injection site reaction (including erythema, pain, bruising)^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, myalgia, musculoskeletal pain, arthralgia (1.8%)^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Neurocognitive events (0.2%)^[Ref]

Other

Common (1% to 10%): Influenza, fatigue (1.6%)
Uncommon (0.1% to 1%): Contusion^[Ref]

Respiratory

Common (1% to 10%): Influenza, fatigue (1.6%)
Uncommon (0.1% to 1%): Contusion^[Ref]

Immunologic

Rare (less than 0.1%): Development anti-drug antibody^[Ref]

Not all side effects for evolocumab may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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